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ECQNWFP: Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan

Sponsor
London School of Hygiene and Tropical Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01019408
Collaborator
European Union (Other), United Nations High Commissioner for Refugees (Other), World Health Organization (Other)
163
Enrollment
3
Locations
2
Arms
14
Duration (Months)
54.3
Patients Per Site
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to provide stronger evidence for extended-dose chloroquine treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP), Pakistan or justification for discontinuation of the policy.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

To determine whether extended-dose chloroquine provided better cure rates and fewer recrudescences than standard chloroquine treatment among Afghan refugees, 163 falciparum patients from three Afghan refugee camps were recruited into 3-day (CQ 25mg/kg) or 5-day (CQ 40mg/kg) treatment arms and followed for up to 60 days.

Study Design

Study Type:
Interventional
Actual Enrollment :
163 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Trial of Extended-dose Chloroquine Versus Standard Chloroquine Treatment for Resistant Falciparum Malaria Among Afghan Refugees in NWFP Pakistan
Study Start Date :
Nov 1, 1993
Actual Primary Completion Date :
Jan 1, 1995
Actual Study Completion Date :
Jan 1, 1995

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CQ25

Falciparum positive patients receiving standard 3-day treatment course of CQ 25mg/kg.

Drug: Chloroquine
Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan
Other Names:
  • CQ

    		•
    Active Comparator: CQ40

    Falciparum positive patients receiving a 5-day treatment course of CQ 40 mg/kg.

    Drug: Chloroquine
    Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan
    Other Names:
  • CQ

    		•

    Outcome Measures

    Primary Outcome Measures

    1. therapeutic and parasitological cure with no recrudescence [60 days]

    Secondary Outcome Measures

    1. parasite clearance time [28 days]

    2. fever clearance time [28 days]

    3. gametocytaemia [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • slide-confirmed infection with P. falciparum only

    • initial parasite density of 1000-100,000 asexual parasites/μl

    • absence of severe malnutrition

    • ability to attend stipulated follow-up visits and easy access to facility

    • informed consent provided by patient or parent/guardian

    • absence of history of hypersensitivity reactions to CQ

    Exclusion Criteria:

    • infants under six months old

    • pregnancy or lactation

    • underlying chronic severe illness

    • patients with other febrile illnesses

    • parasitaemia outside the range of 1000-100,000 asexual parasites/µl

    • severe malaria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Adezai Basic Health Unit Adezai Nwfp Pakistan
    2 Baghicha Basic Health Unit Baghicha Nwfp Pakistan
    3 Kagan Basic Health Unit Kagan Nwfp Pakistan

    Sponsors and Collaborators

    • London School of Hygiene and Tropical Medicine
    • European Union
    • United Nations High Commissioner for Refugees
    • World Health Organization

    Investigators

    • Principal Investigator: Mark Rowland, PhD, LSHTM

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01019408
    Other Study ID Numbers:
    • NH-HNI01
    First Posted:
    Nov 25, 2009
    Last Update Posted:
    Nov 25, 2009
    Last Verified:
    Nov 1, 2009
    Keywords provided by , ,
    Clinical Trial
    Chloroquine
    Refugees
    Afghanistan
    Pakistan
    Additional relevant MeSH terms:
    Malaria
    Malaria, Falciparum
    Chloroquine

    Study Results

    No Results Posted as of Nov 25, 2009